Challenges in achieving total enrollment for your NASH clinical trial are everywhere—low awareness of the condition, extremely complex diagnosis pathways, high screen/failure rates, and a highly competitive landscape just to name a few. Study sites will be under immense and immediate pressure to mine and screen patients from their database, and will also need to contact, schedule, and screen a high number of patients from outreach. Without focused support, including physician education and focused coaching for site staff, your sites will not succeed in supporting and enrolling your NASH trial.
Targeted Site Support
Sponsors will be heavily reliant on sites to screen and randomize patients from their databases, since low awareness will make a central recruitment campaign more difficult. The multitude of comorbid conditions and lack of a standard patient profile will make chart-flagging time-consuming and lead to a high screening volume of ultimately unqualified patients.
Sites must plan for the long diagnosis pathway and will need coaching on how best to manage the diagnostic process. Screening assessments should be performed from least invasive to most invasive, eliminating patients as you move through the process. This means FibroScan® first, then blood draw, then MRI and DXA Scan, then, finally, a biopsy. Based on our experience, if sites start with 100 patients who have been diagnosed with liver disease, as few as 14 of those will end up qualifying for the study by the time they get to the biopsy. This is a long and arduous process and the logistics are complicated because most sites conducting NASH clinical trials will not have all of these diagnostic capabilities on their premises. This means that sites may need to contract with as many as 3 local diagnostic centers and shuffle their patients to each of these centers for assessments. If biopsies can’t be performed at the site—often the case if the site is not an academic center—then the site will be required to schedule a biopsy with a local academic center/hospital, and the wait times for those appointments can be weeks long.
Sites will need to prepare for these challenges, and plan for the time associated with a high volume of screenings.
A dedicated site engagement team will have multiple benefits to trial enrollment:
- provide site staff with coaching or hands-on help to identify the most qualified patients from their databases
- provide actionable recommendations on how to organize the multiple screening tests
- help sites establish and maintain a physician referral network, or establish one on sites’ behalf, depending on site bandwidth
- help sites process referrals that come from recruitment campaigns, ensuring referrals are not lost to follow-up and improving campaign ROI
- keep study top-of-mind—essential in this highly competitive landscape
- prevent site staff from becoming discouraged by high screen-failure rates
Solution: Physician Referral Networks
Sites and institutions that are centers of excellence and who see and diagnose NASH patients most frequently are often selected as study sites. These sites will not have enough patients to fill a study, so engaging community sites and physicians is a necessity. Some community physicians will have already diagnosed NASH patients, so a site engagement team doing a landscape assessment will quickly identify and engage those physicians. Engaging these physicians with educational materials that clearly communicate potential study value and identify the study parameters is a foundational step to successfully enrolling NASH trials.
Establishing a physician referral network that includes robust education on clinical trial options will have two primary benefits:
- encourage more doctors to screen and ultimately diagnose patients, since part of the reason for low diagnosis is the lack of treatment options, and
- help sites obtain more qualified referrals, easing some of the burden of high screen failure rates from their own patients
To successfully enroll your NASH trial, you need a recruitment partner who has a proven site engagement team that can navigate the intricacies of site staffing, understand the nuances of different site types, quickly establish and scale a physician referral network, and assess which type of support will be essential and welcome at each site.
